Table 3 Secondary outcomes of the trial
Secondary outcomes | |
|---|---|
ACR50 | ACR response was used to evaluate improvement in RA. ACR response requires the collection of the degree of improvement in the number of joints with pressure pain and the degree of improvement in the number of joints with swelling and the degree of improvement in 3 of the following 5 items: patient’s assessment of pain, patient’s overall assessment of disease activity, physician’s overall assessment of disease activity, patient’s assessment of physical function (HAQ), and values of acute phase reactants (ESR, CRP). Percentage improvement in each indicator = (pre-treatment value − post-treatment value)/pre-treatment value * 100% ACR20: ≥ 20% improvement in joint pain and swelling, and ≥ 20% improvement in at least 3 of the other 5 items ACR50: ≥ 50% improvement in joint pain and swelling, and ≥ 50% improvement in at least 3 of the other 5 items ACR70: ≥ 70% improvement in joint pain and swelling, and ≥ 70% improvement in at least 3 of the other 5 items |
VAS | Patients’ joint pain levels were evaluated using the VAS, expressed on a ten-point scale, with higher scores indicating more intense pain Face-to-face or telephone follow-ups were conducted at baseline, 4 weeks, 8 weeks, and 12 weeks of treatment, and patients were scored based on their subjective perceptions |
FS-14 | FS-14 is used to measure the patient’s fatigue level. FS-14 was divided into 2 dimensions: physical fatigue (8 items) and mental fatigue (6 items). The scoring method is based on a 2-point scale, with 0 points for “No” and 1 point for “Yes”, and reverse scoring for items 10, 13 and 14, with a total score of 0 to 14 points, with higher scores representing heavier fatigue Face-to-face or telephone follow-ups were conducted at baseline, 4 weeks, 8 weeks, and 12 weeks of treatment, and patients were scored based on their subjective perceptions |
HAQ-DI | The HAQ-DI was used to assess the overall functional status of the patients. The questionnaire consists of 20 questions containing 8 areas of daily activity, with higher scores on each question representing poorer functioning Face-to-face or telephone follow-ups were conducted at baseline, 4 weeks, 8 weeks, and 12 weeks of treatment, and patients were scored based on their subjective perceptions |
Symptom score | The patient’s symptoms associated with RA were recorded, including joint swelling, pressure pain, activity level, diet, etc. The greater the degree of performance of each symptom, the higher the score Face-to-face or telephone follow-ups were conducted at baseline, 4 weeks, 8 weeks, and 12 weeks of treatment, and patients were scored based on their subjective perceptions |
Biological markers | All patients will have their venous blood and other required specimens collected on an empty stomach in the early morning of the specified date and tested in the testing department of each research center, and the biological samples will be frozen in a special refrigerator in China-Japan Friendship Hospital Routine blood, urine, and stool tests were performed at baseline, 4 weeks, and 12 weeks of the trial Electrocardiograph, ALT, AST, and serum creatinine were tested at baseline, 4 weeks, and 12 weeks of the trial to monitor the safety of drug administration ESR and CRP were measured at baseline and 12 weeks of the trial to monitor inflammation levels RF and ACPA were tested during the baseline period of the trial to determine the patient’s antibody levels Additional blood samples were collected at baseline, week 12 of the trial and used to test for various proteins and genes such as inflammatory cytokines |